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FDA Adds Info on Facility Definition, on-Farm Prevention to FAQ on FSMA

The Food and Drug Administration has updated the Prevention section of its frequently asked questions document on the Food Safety Modernization Act to add one FAQ on when FDA will issue a proposed rule to address certain circumstances involving: 1) activities that constitute on-farm packing or holding of food and 2) activities that constitute on-farm manufacturing or processing of food. According to the question, this rulemaking is to clarify the activities that are included as part of the definition of the term "facility."

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Will Clarify Activities Included as Part of Definition of "Facility" in Preventive Controls Proposed Rule

FDA responds that the rule to clarify activities that are included as part of the definition of the term “facility” will be proposed as part of the rulemaking for the preventive controls regulation. It adds that there will be an opportunity for public comment when FDA publishes the proposed rule in the Federal Register.